FR3087116A1 - DEVICE FOR HOLDING TUBES OF INJECTION DEVICE - Google Patents

Abstract

The invention relates to a holding device (10) intended to hold tubes (2) of an injection device of the type comprising an upper flange (8) at one end of a body (4) and a lower flange (6). at the opposite end of the body (4), this device comprising orifices (12) designed to each receive a tube, each orifice being configured to allow the tube and each of its flanges to pass, and the device comprising a holding means ( P) configured to hold the tube through the orifice by its upper flange, the holding means having at least one elastically deformable element (22), said element comprising a holding end (18) located at the right of the orifice and configured to deform when the upper flange passes through the opening, and to support the tube by said flange when it is inserted into the opening.

Description

DEVICE FOR HOLDING TUBES OF INJECTION DEVICE

The present invention relates to a device for holding tubes of a drug injection device, as well as a method of implementing such a device for holding tubes of a drug injection device.

The syringes usually used for injection with a needle, comprising a piston pushed by an operator, generally comprise a tube having a collar at a so-called upper end.

In the remainder of the text, the terms "upper", "lower", "horizontal", "vertical", "top", "bottom", etc. will be used. without limitation and with reference to the device in the position of use.

Another known type of injection device, presented in particular in document FR-A1-3038232, performs intradermal, subcutaneous or intramuscular injections of active principles contained in a fluid for therapeutic use in medicine for humans or in veterinary Medicine. The fluid can be a gel or a more or less viscous liquid. These devices are for single use and contain an energy source such as a pressurized gas generator, delivering a gas suddenly released on a piston adjusted in a cylinder formed by a glass tube having a flange at each end, to propel the fluid. contained under this piston towards an injection nozzle in contact with the skin, and inject it below this skin. The flanges generally have similar diameters.

The glass tubes for injection device, in particular without needles, undergo during their preparation a complete cycle carried out in an air-controlled environment, successively comprising washing, drying, deposition of silicone, depyrogenation and final sterilization.

For the tube preparation cycle comprising a single flange, they are inserted into circular retaining orifices formed on a plate, the single flange forming flanges coming to bear above the orifices, and holding these tubes vertically. In this way a set of tubes arranged in the same tray is easily manipulated in different devices to carry out the succession of preparation operations. The handling of the tubes is simple, fast and secure.

This type of holding device can also be used for the cycle of preparing tubes having flanges of different size at each end, the flange of the upper end of the tube being of greater size than that of the lower flange.

However, for tubes, in particular made of glass, comprising a flange at each end having similar dimensions, such a plate cannot be used because the circular retaining orifices having a diameter sufficient to receive the flanges of the tube, could then not retain the collar of the upper end.

For this purpose, it is known to have a tray comprising orifices provided for each receiving the body of the tube, each orifice comprising a holding part having dimensions smaller than the flanges so as to allow the collar of the flange to be vertically blocked. upper end of the tube, the holding part extending laterally by an insertion part allowing the passage of the flanges.

This type of holding device allows an operator to introduce the flange of the lower end of each tube into the insertion part, then slide this tube vertically towards the holding part. The tube is then held vertically by its upper collar retained above the bore.

Such a tray, although satisfactory as a whole, is capable of improvement, in particular with the aim of increasing the number of tubes held by a holding device, so as to increase the number of tubes prepared during a preparation cycle in order to increase production capacity.

The object of the present invention is in particular to avoid these drawbacks of the prior art.

To this end, it provides a holding device provided for holding tubes of the injection device of the type comprising an upper flange at one end of a body and a lower flange at the opposite end of the body, this device comprising orifices provided to each receive a tube, the device being remarkable in that each orifice is configured to let the tube and each of its collars pass, and in that the device comprises a holding means configured to hold the tube through the orifice by its upper flange, the retaining means having at least one elastically deformable element, said element comprising a retaining end situated in line with the orifice and configured to deform when the upper flange passes through the orifice, and for supporting the tube by said collar when it is inserted into the orifice.

The holding device is for example a tray.

In the following description, the term “tray” means any holding device.

The element is elastically deformable so that it is configured to be mechanically constrained by the upper flange and to deform in its path.

The holding end is configured to support the tube by its upper flange when the mechanical stress is removed.

It advantageously defines a holding surface.

By "located at the right of the orifice" is meant the fact that the holding end is located in the orifice or on the path of the tube when it is inserted into the orifice.

The holding means is configured to hold a tube in the support position through the orifice.

More particularly, the holding means is configured to hold the tube vertically, the upper flange of the tube resting on the holding end.

An advantage of this tray is that in a simple, rapid and efficient manner, an operator can introduce each tube into an orifice, the tube then being held vertically by its upper flange.

In addition, the orifices of this tray are such that they save space on the tray, so as to allow the storage of additional tubes, compared to the prior art.

The tray according to the invention may further include one or more of the following characteristics, which can be combined with one another.

In particular, the holding means is configured to be at least partially in contact with the body of the tube when the tube is inserted into the orifice, which allows additional holding of the tube.

According to one characteristic, the holding means is integral with the plate.

The holding means and the plate are in one piece.

In one embodiment, the holding means projects upward.

According to one characteristic, the holding means forms a wall for the orifice, the wall projecting from the plate.

By wall is meant a projecting element which encircles the orifice, said element being able to be perforated by including spaces.

This wall increases the retention of the tubes in the tray.

According to this characteristic, the wall has a proximal end in contact with the plate and a distal end forming the holding end located at the right of the orifice, said holding end forming an opening configured to deform during the passage of the upper flange. of the tube through the orifice and to support the tube by said collar when it is inserted into the orifice.

The opening is smaller than the opening and configured to be smaller than the top flange of the tube.

The wall is elastically deformable so that it is configured to move apart when the upper flange passes.

Advantageously, the elastically deformable element has at least two legs, preferably between three and ten legs and more preferably six legs.

The legs advantageously form the wall.

In this way, the wall has spaces arranged between the legs, which allow said wall to move apart when the upper flange passes through the orifice.

According to one characteristic, the orifice is configured to be complementary to the upper flange.

By “complementary” is meant that the shape of the orifice is substantially identical to that of the upper flange, but its dimensions are slightly greater to allow the passage of said flange during the introduction of the tube into the orifice.

In this way, no space is lost on the set, which optimizes production capacities.

Advantageously, the tray comprises a plastic material comprising liquid crystal polymers, implemented by injection. This plastic material has both good rigidity, resistance to various chemical agents and resistance to high temperatures for dry sterilization.

It will be noted that the plate as described above is configured to hold tubes of the type comprising a single flange at an upper end of a body, and / or tubes of the type comprising an upper flange and a lower flange, the upper flange being of dimension greater than or equal to the lower flange.

The invention also relates to a method of implementing a tray as described above, for holding tubes of the drug injection device, in which a tube is introduced vertically into each orifice of the tray.

In the embodiment according to which the holding means projects upwards, the method of implementing the plate comprises a step of introducing a tube into each orifice from the bottom of the plate.

Other characteristics and advantages of the invention will appear on reading the following detailed description for the understanding of which reference will be made to the appended drawings in which:

Figure 1 is a schematic side perspective view of a needleless injection device tube of the type having a flange at each end of a body;

Figure 2 is a schematic perspective view from above of a tray with orifices according to the invention, intended to receive the tubes of Figure 1;

Figure 3 is a schematic perspective view of an orifice of the tray of Figure 2;

Figure 4 is a schematic top view of the orifice of Figure 3;

Figure 5 is a schematic side view of a detail of the tray of Figure 2, tubes being inserted into the holes.

The terms "upper", "lower", "front", "rear", "top", "bottom" and their derivatives refer to the position or orientation of an element or component, this position or this orientation being considered when the plate is in configuration of use.

FIG. 1 represents a glass tube 2 of an injection device, comprising a cylindrical body 4 having a lower flange 6 at one end of the body 4 and an upper flange 8 at the opposite end of the body 4, each forming an outer bead of revolution around the main axis of the body.

The upper 8 and lower 6 flanges are circular.

The glass tube 2 can be used in particular by the injection device presented above and illustrated by the document of the prior art FR-A13038232.

FIG. 2 illustrates a plate 10 of rectangular shape.

Advantageously, the plate 10 is produced by injection molding of a plastic material comprising liquid crystal polymers, called “LCP” (acronym of the English terms “Liquid Crystal Polymer”), which are materials with high mechanical performance resistant to the cycle of dry heat at 240 ° C, as well as various chemical agents.

The tray 10 comprises a flat plate 24 comprising, in the middle of two opposite sides, a notch 14 facilitating the handling of this tray.

The plate 10 comprises eight identical rows, parallel to the sides comprising the notches 14, of seven circular orifices 12.

Each orifice 12 is designed to receive a glass tube 2 which is held vertically, with its axis perpendicular to this plate (figure

5).

As illustrated in more detail in FIG. 3, each orifice 12 has six tabs 22 projecting upwards from the plate, forming a wall P for the orifice, perforated by spaces 13 between the tabs 22.

The six tabs 22 are oriented at 30 °.

In variants not shown, the orifice has three legs or four legs.

The presence of the six legs is advantageous because it allows better retention of the tubes

This perforated wall P is configured to hold a tube 2 through the orifice 12, by its upper flange 8, as will be described in more detail with reference to FIG. 5.

The wall P is a means of holding a tube.

Each tab 22 has a proximal end 16 in contact with the plate 24 of the plate 10 at the contour of the orifice 12, and a distal end called the retaining end 18, located at the right of the orifice 12.

Thus, each tab 22 is integral with the plate 10 and the holding end 18 is located on the path of the tube 2 when it is inserted through the orifice.

Each tab 22 is elastically deformable so that it is adapted to deform during the passage of the upper flange 8 from the proximal end 16 to the holding end 18, and to support the upper flange 8 when the tube 2 is inserted through the orifice 12, as illustrated in FIG. 5.

Thus, each tab is configured to be mechanically constrained by the upper flange 8 and to deform on its passage.

The holding end 18 is configured to support the tube 2 by its upper flange 8 when the mechanical stress is removed.

The holding ends 18 of each tab 22 of an orifice 12 define a holding surface located at the right of the orifice.

The retaining surface forms an opening 20 (FIG. 4) situated in line with the orifice 12, configured to deform during the passage of the upper flange 8 and to support the tube 2 by its upper flange 8 when it is inserted at through port 12, as shown in Figure 5.

Furthermore, each tab 22 has a proximal portion 26 oblique upward, starting from the proximal end 16 towards the interior of the orifice 12, and a distal portion 28 vertical upward, starting from the proximal portion 26 towards the holding end 18.

In addition, the height of each tab 22 is between 10 and 25 mm, preferably 18.5 mm in order to ensure vertical retention of the tubes 2 inserted in the orifices 12.

The height of the proximal portion 26 is between 10 and 15 mm, and preferably 13 mm, while the height of the distal portion 28 is between 3 mm and 5 mm, and preferably 4 mm.

As shown in Figure 4, the diameter "d" of the opening 20 is 12.2 mm, while the diameter "D" of the orifice 12 is 16 mm.

Thus, the opening 20 is smaller in size than the orifice 12.

In addition, the upper flange 8 has a diameter of the order of 14 mm. It is therefore of complementary dimension to the orifice 12 but of dimension greater than the opening 20.

FIG. 5 illustrates a part of the plate 10 comprising tubes 2 inserted in orifices 12 as described above, the plate 10 being adjusted in a standardized support 30 forming a contour, also called "Tub", allowing positioning in different devices of treatment of glass tubes 2.

The plate 10 includes lights 17 in the form of a "keyhole" which are used for gripping the plate when it is extracted from the support 30.

Each orifice 12 is configured to allow a tube 2 and each of its flanges 6, 8 to pass through.

The wall P of an orifice 12, formed by the tabs 22, is configured to maintain the tube 2 in the support position through the orifice 12.

Thus, each tube 2 is held vertically, the upper flange 8 resting on the holding end 18 of the legs 22.

The tabs 22 are configured to be at least partially in contact with the body 4 of the tube 2 inserted in the orifice 12, which allows additional retention of the tube.

It is the distal portion 28 of the legs 22 which is in contact with the body 4 of the tube 2 when it is inserted into an orifice 12.

The distal portion 28 is substantially adjusted around the body 4 of a glass tube 2.

For the introduction of a tube 2 into an orifice 12, the tube 2 is introduced vertically into the orifice 12, from the bottom of the plate 10.

When the tubes 2 have been introduced into the orifices 12 of the plate 10, a bag of the complete plate 10 with its support 30 is then made into a bag, and this bag is sealed to sterilize the tubes.

Plastic bags are used using high density polyethylene, which can in particular be a material sold under the registered trademark "Tyvek", allowing reduced moisture passage, good heat conduction, a strong microbial barrier, and high mechanical resistance, in particular for resistance to punctures.

The final packaging is carried out according to the French standard “NF ISO 11040-7”, specifying the packaging of systems for delivering sterilized tubes ready to be filled.

After washing the tubes 2, a coating of silicone is carried out, followed by sterilization by a process of reduction of the pyrogens comprising heating with dry heat to obtain a strong reduction of the endotoxins which are pyrogens.

In particular, a heating cycle in dry heat at 240 ° C. has the advantage of carrying out crosslinking of the silicone at the same time, which subsequently avoids rejection of this silicone in the medicament after filling the glass tube 2, and during the final use of the injection device on the patient. In addition, this process avoids sterilization with ethylene oxide which introduces toxic materials.

Claims (10)

1. Holding device (10) designed to hold tubes (2) of the injection device of the type comprising an upper flange (8) at one end of a body (4) and a lower flange (6) at the opposite end of the body (4), this device (10) comprising orifices (12) provided for each receiving a tube (2), the device (10) being characterized in that each orifice (12) is configured to let the tube (2) and each of its collars (6, 8), and in that the device (10) comprises a holding means (P) configured to hold the tube (2) through the orifice (12) by its upper flange (8), the retaining means (P) having at least one elastically deformable element (22), said element (22) comprising a retaining end (18) located in line with the orifice (12) and configured for deform during the passage of the upper flange (8) through the orifice (12), and to support the tube (2) by ladi the collar (8) when it is inserted into the orifice (12). 2. Device according to the preceding claim, wherein the holding means (P) is configured to be at least partially in contact with the body (4) of the tube (2) when the tube (2) is inserted in the orifice ( 12). 3. Device according to any one of the preceding claims, in which the holding means (P) projects upwards. 4. Device according to any one of the preceding claims, in which the holding means (P) forms a wall for the orifice (12), the wall projecting from the device (10). 5. Device according to the preceding claim, wherein the wall (P) has a proximal end (16) in contact with the device (10) and a distal end forming the retaining end (18) located at the right of the orifice ( 12), said holding end (18) forming an opening (20) configured to deform during the passage of the upper flange (8) of the tube (2) through the orifice (12) and to support the tube (2 ) by said flange (8) when it is inserted into the orifice (12. 6. Device according to any one of the preceding claims, in which the elastically deformable element (22) has at least two legs (22), preferably between three and ten legs (22), and more preferably six legs (22 ). 7. Device according to the preceding claim in combination with any one of claims 4 to 5, wherein the tabs (22) advantageously form the wall (P). 8. Device according to any one of the preceding claims, in which the orifice (12) is configured to be complementary to the upper flange (8). 9. Method for implementing a device according to any one of 5 preceding claims, for holding tubes (2) of a drug injection device, in which a tube (2) is inserted vertically into each orifice (12) of the device (10). 10. A method of implementing a device (10) according to any one of claims 3 to 8 in combination with claim 3, wherein a tube 10 (2) is introduced vertically into each orifice (12) from the bottom of the device (10).